New substance

According to article 4, paragraph 1, letter a of ChemA, new substances are defined as those which are not existing substances. Thus, new substances are those (no longer) fully registered under REACH in the EU.

New substances are therefore substances
• which are not (or no longer) fully registered in the EU under REACH
• are only registered as intermediates (except monomers)
• are placed on the market in a higher quantity category than they are registered in the EU

Existing substance
An existing substance is a substance that
• is fully registered
• is not only registered as an intermediate (except monomers)
• is not placed on the market in a higher tonnage category than it is registered in the EU

Obligations concerning new substances
New substances that are placed on the market in Switzerland (including those imported for professional or commercial purposes) are subject to notification requirements under Chemicals Ordinance.
• The notifier (manufacturer, importer or only representative) must have his habitual residence, registered office or subsidiary in Switzerland.
• New substances which have already been registered in the EU are nonetheless subject to the requirement for notification in Switzerland.
• New substances are also subject to self-regulation requirements under Article 5 of the ChemO.
• The obligation to notify is generally applicable for quantities of more than 1 ton per manufacturer or importer (Swiss quantity).

Substances, which must be notified, do not have to be additionally reported to the product register (RPC).
Manufacturers of new substances that are exempt from notification according to article 26 let. a, c, g, h, j, ChemO, must report these within 3 months after first placing them on the market and independently of the obligation to establish a SDS (art. 48, art. 19 ChemO):
a. dangerous substances
b. substances assessed as PBT or vPvB;
c. substances in annex 3 ChemO (candidate list)
d. nanomaterials purposefully containing fibres or tubes with a length of more than 5 μm. Materials with a water solubility of less than 100 mg per liter or with a half-life of 40 days or more in the lungs are considered being biopersistent.Exemptions to the obligation to report are listed in Article 54 ChemO.

Declaration (PPORD)
The notification authority for chemicals must be informed of substances which do not have to be notified (art. 26 par. 1 let. e ChemO) and which are intended solely for product and process-orientated research and development (PPORD, art. 34 ChemO).

Last modification 12.05.2022

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